# FDA 483 - Ortho-Clinical Diagnostics, Inc. - May 10, 2019

Source: https://www.globalkeysolutions.net/records/483/ortho-clinical-diagnostics-inc/a63460f5-24d0-407b-ab3a-1a74a1013bc5

> FDA 483 for Ortho-Clinical Diagnostics, Inc. on May 10, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Ortho-Clinical Diagnostics, Inc.
- Inspection Date: 2019-05-10
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Ortho Clinical Diagnostics in Rochester, NY, from April 29 to May 10, 2019, revealed a significant quality system deficiency. The firm failed to adequately establish corrective and preventive action (CAPA) procedures. Specifically, no CAPA was created to address the root cause of a product recall initiated in October 2018 for VITROS analyzer systems, indicating a breakdown in their post-market surveillance and quality control processes.

## Related Documents

- [483 - 2025-05-22](https://www.globalkeysolutions.net/records/483/ortho-clinical-diagnostics-inc/7844df72-8fe1-413e-a519-5297454a2f44)

## Related Officers

- [Matthew D. Schnittker](https://www.globalkeysolutions.net/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.globalkeysolutions.net/companies/ortho-clinical-diagnostics-inc/87658237-768e-419e-95c9-498cdd89acf6

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961